79 / 129
Method Validation Report
Version
1
Page
43 of 49
Document Title
Validation Report for the Determination of Thiamin HCl, Riboflavin, Niacin
(Nicotinic Acid and Nicotinamide), Pantothenic acid, Vitamin B6
(Pyridoxine, Pyridoxal and Pyridoxamine) and Biotin in Infant Formula and
Adult Nutritionals by LC-MS/MS
Table 44: Accuracy of Pantothenic acid in Partially hydrolyzed protein infant formula
powder
Over
Spike
Replicates
Pantothenic acid (mcg/100g)
Un-
spiked
Result
Spiked
Result
Resulting
Spiked
Conc
Theoretical
Spiked
Conc (C)
%
Recovery
Acceptable
(A)
(B)
(A+C)
B/(A+C)
Y/N
0%
Replicate 1 3265.82
Mean
Replicate 2 3521.59
3438.94
Replicate 3 3529.40
40%
Replicate 1
5082.27 4866.68
1427.74
104.43
Y
Replicate 2
4859.46 4866.68
1427.74
99.85
Y
Replicate 3
4878.57 4866.68
1427.74
100.24
Y
80%
Replicate 1
6249.83 6294.42
2855.49
99.29
Y
Replicate 2
6372.27 6294.42
2855.49
101.24
Y
Replicate 3
6318.17 6294.42
2855.49
100.38
Y
Acceptance Criteria: All individual recovery results should be within 90 % to 110 %.
BVIT-01 (SLV)
FOR ERP/WORKING GROUP USE ONLY
DO NOT DISTRIBUTE
Page 56